Flunarizine hydrochloride capsule and its preparation method

A technology of flunarizine hydrochloride and capsules, which is applied in the field of flunarizine hydrochloride capsules and its preparation, and can solve problems affecting bioavailability and curative effect

Inactive Publication Date: 2006-10-04
周有财
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The Flunarizine Hydrochloride Capsules overcomes the current problem that the larger particles of the drug powder in th

Method used

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  • Flunarizine hydrochloride capsule and its preparation method
  • Flunarizine hydrochloride capsule and its preparation method
  • Flunarizine hydrochloride capsule and its preparation method

Examples

Experimental program
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Effect test

Embodiment 1

[0022] Get 10 kilograms of superfine powder, 15 kilograms of starch, 25 kilograms of lactose, 15 kilograms of talcum powder, 0.5 kilogram of magnesium stearate. 10 kg of the superfine powder is firstly mixed with 15 kg of starch and 25 kg of lactose, then mixed with 15 kg of talcum powder and 0.5 kg of magnesium stearate, and finally packed into capsules to be prepared.

Embodiment 2

[0024] Get 5 kilograms of superfine powder, 10 kilograms of starch, 20 kilograms of lactose, 10 kilograms of talcum powder, 0.2 kilogram of magnesium stearate. 5 kg of the superfine powder is firstly mixed with 10 kg of starch and 20 kg of lactose, then mixed with 10 kg of talcum powder and 0.2 kg of magnesium stearate, and finally packed into capsules.

Embodiment 3

[0026] Get 20 kilograms of superfine powder, 20 kilograms of starch, 30 kilograms of lactose, 20 kilograms of talcum powder, 0.8 kilogram of magnesium stearate. 20 kg of the superfine powder is firstly mixed with 20 kg of starch and 30 kg of lactose, then mixed with 20 kg of talcum powder and 0.8 kg of magnesium stearate, and finally packed into capsules to be prepared.

[0027] Can be reflected by comparative bioavailability. The following compares the bioavailability of the flunarizine hydrochloride capsules produced by the two production processes through the bioequivalence test, that is, comparing the flunarizine hydrochloride capsules produced by the applicant with the ultrafine pulverization production process and the applicant's non-ultrafine production process. The human bioavailability of flunarizine hydrochloride capsules produced by crushing process was compared with that of flunarizine hydrochloride capsules produced by Shandong Fangming Pharmaceutical Co. Cinnari...

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Abstract

The invention relates to a Flunarizine hydrochloride capsule and its preparing process, wherein the capsule contains ultramicro-powders of flunarizine hydrochloride with internal diameter less than 10 mum, and the preparing process comprises disintegrating Flunarizine hydrochloride raw material, mixing the obtained ultramicro-powder with starch and lactose, then mixing with talcum powder and magnesium stearate, finally loading into capsule and packaging.

Description

technical field [0001] The invention relates to a dosage form and a preparation method of flunarizine hydrochloride, in particular to a flunarizine hydrochloride capsule and a preparation method thereof. technical background [0002] The chemical name of flunarizine hydrochloride is (E)-1-[bis(4-fluorophenyl)methyl]-4-(2-propenyl-3-phenyl)-piperazine dihydrochloride, which is Bifluorinated derivatives of piperazine are mainly used clinically for cerebrovascular diseases. Flunarizine hydrochloride mostly exists in the form of capsules. The production technology of flunarizine hydrochloride capsules currently on the market is as follows: the raw material powder is passed through a 100-120 mesh (particle size 125-150 μm) sieve, and an appropriate amount of excipients are added. , into empty capsules. For its preparation process, please refer to figure 1 . However, flunarizine hydrochloride is insoluble in water. If the powder particles in the capsule are large, it will affe...

Claims

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Application Information

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IPC IPC(8): A61K31/495A61K9/48A61P9/10
Inventor 周有财
Owner 周有财
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